Actively Recruiting
A Phase 2b, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC Against Tuberculosis in Adolescents and Adults Aged 14-45 Years in a TB Endemic Region
Led by International AIDS Vaccine Initiative · Updated on 2026-03-31
5500
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
Sponsors
I
International AIDS Vaccine Initiative
Lead Sponsor
B
Biofabri, SLU
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and immune response of MTBVAC, a candidate vaccine against tuberculosis (TB), in adolescents and adults aged 14 to 45 years living in regions where TB is common. This Phase 2b study is randomized, double-blind, and placebo-controlled, aiming to compare MTBVAC to a placebo in preventing TB disease, particularly in participants who have tested positive or negative for latent TB infection using IGRA tests. Most participants likely received BCG vaccination in infancy. Participants are assigned to receive a single intradermal dose of MTBVAC at 5x10^5 CFU or placebo on Study Day 1. Those who test IGRA-positive at baseline are randomized 1:1 to either MTBVAC or placebo, while IGRA-negative participants are randomized 3:1. Subgroups of participants will be closely monitored for safety and immune responses, with specific evaluations in selected safety and immunogenicity sub-cohorts. The study also includes follow-up screening for pulmonary TB disease and HIV testing yearly and during suspected TB episodes. During the study, participants will attend regular visits or have contacts to monitor for TB signs and symptoms, with sputum tests performed if TB is suspected. Safety assessments include monitoring adverse events and laboratory tests in sub-cohorts. The main outcome is the protective effect of MTBVAC against bacteriologically confirmed pulmonary TB over 36 months, along with safety and immune response evaluations. Participants diagnosed with TB will be referred for standard treatment, and those who seroconvert for HIV will receive appropriate care. The study runs until March 2028.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 14 through 45 years on Study Day 1
- Completed informed consent process (written consent or parental consent and participant assent if under 18)
- Able and willing to comply with study requirements and follow-up visits
- Generally healthy based on medical history and physical exam
- Females who could become pregnant must use accepted contraception from 21 days before vaccination until 2 months after
- Males must use barrier contraception with female partners for at least 2 weeks after vaccination
- No close contact with someone diagnosed with TB in the past 6 months
- HIV negative at screening
- Negative clinical screening and negative sputum test for active pulmonary TB at screening
You will not qualify if you...
- Acute illness or fever (≥37.5°C) on Study Day 1
- Active TB disease or suspicion of TB at screening
- History of TB disease or treatment
- Prior TB preventive therapy (excluding BCG vaccine)
- Use of investigational drugs or vaccines within 42 days before enrollment
- Planned use of licensed vaccines not in the study protocol from 28 days before to 28 days after vaccination
- Previous receipt of investigational TB vaccine (except prior placebo with approval)
- Recent use of immunosuppressive medication within 42 days before enrollment (except inhaled or topical corticosteroids)
- Known or suspected immunosuppressive, immunodeficient, or autoimmune conditions
- Participation in other investigational studies during this study (except observational studies without blood or tissue sampling)
- Received immunoglobulin or blood products within 42 days before enrollment
- History of allergic reactions to vaccine components
- Pregnant or breastfeeding females
- Indeterminate IGRA test result at screening
- Conditions or medication use that may affect safety or study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants receive a single dose of MTBVAC vaccine or placebo administered intradermally on Study Day 1.
1 visit (in-person)
Duration - Up to 36 months
Participants are followed for up to 36 months to monitor for tuberculosis infection, safety, and immune response through regular visits and contacts. Participants are trained to recognize and report symptoms of pulmonary TB for clinical evaluation if needed.
Regular visits and contacts throughout follow-up
Trial Site Locations
Total: 16 locations
1
Victoria Biomedical Research Institute
Kisumu, Kenya
Actively Recruiting
2
Kenya Medical Research Institute
Nairobi, Kenya
Actively Recruiting
3
JOSHA Research
Bloemfontein, South Africa
Actively Recruiting
4
South African Tuberculosis Vaccine Initiative
Cape Town, South Africa
Actively Recruiting
5
TASK Applied Science Pty Ltd. TASK Delft
Cape Town, South Africa
Actively Recruiting
6
UCTLI CLII - Centre for Lung Infection and Immunity
Cape Town, South Africa
Actively Recruiting
7
University of Cape Town Lung Institute PtyLtd. Centre for Tuberculosis Research Innovation
Cape Town, South Africa
Actively Recruiting
8
Wellcome Centre for Infectious Diseases Research in Africa
Cape Town, South Africa
Actively Recruiting
9
Synergy Biomedical Research Institute
East London, South Africa
Actively Recruiting
10
TASK Eden Pty Ltd.
George, South Africa
Actively Recruiting
11
Perinatal HIV Research Unit
Johannesburg, South Africa
Actively Recruiting
12
Be Part Research Pty Ltd.
Paarl, South Africa
Actively Recruiting
13
The Aurum Institute Rustenburg Clinical Research Centre
Rustenburg, South Africa
Actively Recruiting
14
Desmond Tutu Health Foundation, Masiphumelele Research Office
Sunnydale, South Africa
Not Yet Recruiting
15
The Aurum Institute Tembisa Clinical Research Centre
Tembisa, South Africa
Actively Recruiting
16
Ifakara Health Institute
Dar es Salaam, Tanzania
Not Yet Recruiting
Research Team
E
Elana Van Brakel, MD
A
Ansuya Naidoo, MBChB
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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